NSCLC
Conditions
Interventions
Single arm:Neoadjuvant treatment with low-dose radiotherapy + stereotactic radiotherapy sequentially combined with Tislelizumab and platinum-based doublet chemotherapy
Sponsors
West China Hospital , Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. A written informed consent must be signed before initiating any trial-related rocedures; 2.Age >= 18 years and 6 months; 10. Adequate organ function is required for the subject to meet the following laboratory indicators: (1) In the past 14 days without the use of granulocyte colony stimulating factor, the absolute value of neutrophils (ANC) >= 1.5x10^9/L; (2) Platelets >= 100x10^9/L without blood transfusion in the past 14 days ; (3) In the absence of blood transfusion or use of erythropoietin within the past 14 days, hemoglobin>9g/dL; (4) Total bilirubin = 60 ml/min; (7) Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) The myocardial enzyme spectrum is within the normal range (if the researcher comprehensively determines that a simple laboratory abnormality without clinical significance is also allowed to be included); 11. Patients who have no contraindications to radiotherapy as determined by the radiologist; 12. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be performed within 3 days before receiving the first dose of the study drug (day 1 of the first cycle). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non reproductive age women are defined as those who have undergone at least one year of menopause or have undergone surgical sterilization or hysterectomy; 13. If there is a risk of conception, all subjects (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1.Pathology of Small Cell Lung Cancer (SCLC), including mixed SCLC and non-small cell lung cancer (NSCLC). 2. Active hemoptysis within 2 weeks prior to the first dose of the investigational drug (at least 1/2 teaspoon of fresh blood per episode). 3. Received major surgical treatment within 3 weeks of the first study drug administration (excluding surgery for biopsy purposes); 4. Diagnosed as other malignant diseases other than NSCLC within 5 years prior to the first administration (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection); 5. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 6. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulus or synergistic inhibition of T cell receptors (such as CTLA-4, OX-40, CD137); 7. Within 2 weeks before the first administration, he received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti lung cancer indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 8. Active autoimmune diseases that require systemic treatment (such as the use of disease relieving drugs, glucocorticoids, or immunosuppressants) have occurred within 2 years prior to the first administration. Alternative therapy (such as thyroxine, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) is not considered systemic treatment; 9. Within 7 days prior to the first administration of the study, the patient is receiving systemic glucocorticoid therapy (excluding local glucocorticoids administered through nasal spray, inhalation, or other means) or any other form of immunosuppressive therapy; 10. Patients with clinically uncontrollable pleural/abdominal effusion (those who do not require drainage of the effusion or do not have a significant increase in effusion after stopping drainage for 3 days can be enrolled); 11. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. Individuals who are known to be allergic to active ingredients or excipients such as , tislelizumab, albumin paclitaxel, and carboplatin in this study drug; 13. Individuals with multiple factors that affect oral medication (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 14. Patients with bleeding tendencies (such as active gastrointestinal ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; On the premise that the international standardized ratio of prothrombin time (INR) is <= 1.5, it is allowed to use low-dose warfarin (<= 1mg/d), low-dose heparin (<= 12000 U/d), or low-dose aspirin (<= 100mg/d) for preventive purposes; 15. Serious arterial/venous thrombotic events such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism occurred within 6 months before the first medication use; 16. Not fully recovered from toxicity and/or complications caused by any intervention measures before starting treatment (i.e. <= level 1 or reaching baseline, e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response(pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response(MPR);R0 rate;Safety; | — |
Countries
China
Contacts
Public ContactXue Jianxin
West China Hospital , Sichuan University
Outcome results
None listed